One Drop App With an Activity Tracker for Adults With Type 1 Diabetes: Randomized Controlled Trial.

BACKGROUND: In 2017, mobile app support for managing diabetes was available to 64% of the global population of adults with diabetes. One Drop's digital therapeutics solution includes an evidence-based mobile app with global reach, a Bluetooth-connected glucometer, and in-app coaching from Certified Diabetes Educators. Among people with type 1 diabetes and an estimated hemoglobin A1c level≥7.5%, using One Drop for 3 months has been associated with an improved estimated hemoglobin A1c level of 22.2 mg/dL (-0.80%). However, the added value of integrated activity trackers is unknown. OBJECTIVE: We conducted a pragmatic, remotely administered randomized controlled trial to evaluate One Drop with a new-to-market activity tracker against One Drop only on the 3-month hemoglobin A1c level of adults with type 1 diabetes. METHODS: Social media advertisements and online newsletters were used to recruit adults (≥18 years old) diagnosed (≥1 year) with T1D, naïve to One Drop's full solution and the activity tracker, with a laboratory hemoglobin A1c level≥7%. Participants (N=99) were randomized to receive One Drop and the activity tracker or One Drop only at the start of the study. The One Drop only group received the activity tracker at the end of the study. Multiple imputation, performed separately by group, was used to correct for missing data. Analysis of covariance models, controlling for baseline hemoglobin A1c, were used to evaluate 3-month hemoglobin A1c differences in intent-to-treat (ITT) and per protocol (PP) analyses. RESULTS: The enrolled sample (N=95) had a mean age of 41 (SD 11) years, was 73% female, 88% White, diagnosed for a mean of 20 (SD 11) years, and had a mean hemoglobin A1c level of 8.4% (SD 1.2%); 11% of the participants did not complete follow up. Analysis of covariance assumptions were met for the ITT and PP models. In ITT analysis, participants in the One Drop and activity tracker condition had a significantly lower 3-month hemoglobin A1c level (mean 7.9%, SD 0.60%, 95% CI 7.8-8.2) than that of the participants in the One Drop only condition (mean 8.4%, SD 0.62%, 95% CI 8.2-8.5). In PP analysis, participants in the One Drop and activity tracker condition also had a significantly lower 3-month hemoglobin A1c level (mean 7.9%, SD 0.59%, 95% CI 7.7-8.1) than that of participants in the One Drop only condition (mean 8.2%, SD 0.58%, 95% CI 8.0-8.4). CONCLUSIONS: Participants exposed to One Drop and the activity tracker for the 3-month study period had a significantly lower 3-month hemoglobin A1c level compared to that of participants exposed to One Drop only during the same timeframe. One Drop and a tracker may work better together than alone in helping people with type 1 diabetes. TRIAL REGISTRATION: ClinicalTrials.gov NCT03459573; https://clinicaltrials.gov/ct2/show/NCT03459573.

One Drop | Mobile on iPhone and Apple Watch: An Evaluation of HbA1c Improvement Associated With Tracking Self-Care.

BACKGROUND: The One Drop | Mobile app supports manual and passive (via HealthKit and One Drop's glucose meter) tracking of self-care and glycated hemoglobin A1c (HbA1c). OBJECTIVE: We assessed the HbA1c change of a sample of people with type 1 diabetes (T1D) or type 2 diabetes (T2D) using the One Drop | Mobile app on iPhone and Apple Watch, and tested relationships between self-care tracking with the app and HbA1c change. METHODS: In June 2017, we identified people with diabetes using the One Drop | Mobile app on iPhone and Apple Watch who entered two HbA1c measurements in the app 60 to 365 days apart. We assessed the relationship between using the app and HbA1c change. RESULTS: Users had T1D (n=65) or T2D (n=191), were 22.7% (58/219) female, with diabetes for a mean 8.34 (SD 8.79) years, and tracked a mean 2176.35 (SD 3430.23) self-care activities between HbA1c entries. There was a significant 1.36% or 14.9 mmol/mol HbA1c reduction (F=62.60, P<.001) from the first (8.72%, 71.8 mmol/mol) to second HbA1c (7.36%, 56.9 mmol/mol) measurement. Tracking carbohydrates was independently associated with greater HbA1c improvement (all P<.01). CONCLUSIONS: Using One Drop | Mobile on iPhone and Apple Watch may favorably impact glycemic control.

One Drop | Mobile: An Evaluation of Hemoglobin A1c Improvement Linked to App Engagement.

BACKGROUND: Three recent reviews evaluated 19 studies testing the hemoglobin A1c (HbA1c) benefit of 16 diabetes apps, including 5 publicly available apps. Most studies relied on small samples and did not link app engagement with outcomes. OBJECTIVE: This study assessed both HbA1c change in a large sample of people using the One Drop | Mobile app and associations between app engagement and changes in HbA1c. METHODS: The One Drop | Mobile app for iOS and Android is designed to manually and passively (via Apple HealthKit, Google Fit, and the One Drop | Chrome blood glucose meter) store, track, and share data. Users can schedule medication reminders, view statistics, set goals, track health outcomes, and get data-driven insights. In June 2017, we queried data on people with diabetes using the app who had entered at least 2 HbA1c values in the app >60 and ≤365 days apart. Multiple imputation corrected for missing data. Unadjusted and adjusted mixed effects repeated measures models tested mean HbA1c change by time, diabetes type, and their interaction. Multiple regression models assessed relationships between using the app to track food, activity, blood glucose, and medications and HbA1c change. RESULTS: The sample (N=1288) included people with type 1 diabetes (T1D) (n=367) or type 2 diabetes (T2D) (n=921) who were 35% female, diagnosed with diabetes for a mean 9.4 (SD 9.9) years, and tracked an average 1646.1 (SD 3621.9) self-care activities in One Drop | Mobile between their first (mean 8.14% [SD 2.06%]) and second HbA1c entry (mean 6.98% [SD 1.1%]). HbA1c values were significantly associated with user-entered average blood glucose 90 days before the second HbA1c entry (rho=.73 to .75, P<.001). HbA1c decreased by an absolute 1.07% (unadjusted and adjusted F=292.03, P<.001) from first to second HbA1c entry. There was a significant interaction between diabetes type and HbA1c. Both groups significantly improved, but users with T2D had a greater HbA1c decrease over time than users with T1D (F=10.54, P<.001). For users with T2D (n=921), HbA1c decreased by an absolute 1.27% (F=364.50, P<.001) from first to second HbA1c entry. Finally, using One Drop | Mobile to record food was associated with greater HbA1c reductions even after adjusting for covariates and after also adjusting for insulin use for users with T2D (all P<.05). CONCLUSIONS: People with T1D and T2D reported a 1.07% to 1.27% absolute reduction in HbA1c during a median 4 months of using the One Drop | Mobile app. Using the app to track self-care was associated with improved HbA1c. More research is needed on the health benefits of publicly available diabetes apps, particularly studies associating app engagement with short- and long-term effects.